Catalog Number 408381 |
Device Problem
Leak/Splash (1354)
|
Patient Problem
No Patient Involvement (2645)
|
Event Date 08/31/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
|
|
Event Description
|
It was reported that spinal needle 27ga 3-1/2in had a hole in a needle hub.The following information was provided by the initial reporter: "*notivisa* crack in the part of insertion of the syringe.".
|
|
Manufacturer Narrative
|
H.6.Investigation: there was no sample or photo available to bd for evaluation.Therefore, bd was unable to perform a thorough investigation to verify the reported issue.Since, an investigation could not be performed bd was unable to determine a possible root cause.A review of the device history record was performed and no quality issues were found during production.H3 other text : see h.10.
|
|
Event Description
|
It was reported that spinal needle 27ga 3-1/2in had a hole in a needle hub.The following information was provided by the initial reporter: "notivisa crack in the part of insertion of the syringe.".
|
|
Search Alerts/Recalls
|